Myopia Progression and the Effect of 7-Methylxanthine

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Trier Research Laboratories Generalkonsul Einar Høyvalds Fond Jørgen Bagenkop Nielsens Myopi-Fond Chr. Andersen og hustru Ingeborg Andersen, f. Schmidts legat (fond) oprettet af deres datter, frk. Lilli Ellen Andersen.
Information provided by:	Trier Research Laboratories
ClinicalTrials.gov Identifier:	NCT00263471

Purpose

7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.

Condition	Intervention	Phase
Myopia	Drug: 7-methylxanthine	Phase II

Drug Information available for: 7-Methylxanthine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia

Further study details as provided by Trier Research Laboratories:

Primary Outcome Measures:

Axial growth

Secondary Outcome Measures:

Myopia progression

Estimated Enrollment:	90
Study Start Date:	October 2003
Estimated Study Completion Date:	March 2006

Detailed Description:

Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months. Axial length, cycloplegic refraction and corneal curvature is measured, as well as weight, height, blood pressure and heart rate. The participants are interviewed about possible CNS, gastrointestinal, or cardiopulmonal side effects.

Eligibility

Ages Eligible for Study:	8 Years to 13 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year.

Exclusion Criteria:

Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263471

Sponsors and Collaborators

Trier Research Laboratories

Generalkonsul Einar Høyvalds Fond

Jørgen Bagenkop Nielsens Myopi-Fond

Chr. Andersen og hustru Ingeborg Andersen, f. Schmidts legat (fond) oprettet af deres datter, frk. Lilli Ellen Andersen.

Investigators

Study Chair:

Klaus Trier, MD

Trier Research Laboratories

More Information

Publications:

Trier K, Olsen EB, Kobayashi T, Ribel-Madsen SM. Biochemical and ultrastructural changes in rabbit sclera after treatment with 7-methylxanthine, theobromine, acetazolamide, or L-ornithine. Br J Ophthalmol. 1999 Dec;83(12):1370-5.

Study ID Numbers:	2612-2320
Study First Received:	December 6, 2005
Last Updated:	December 13, 2005
ClinicalTrials.gov Identifier:	NCT00263471
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Eye Diseases
Disease Progression
Myopia
Refractive Errors

ClinicalTrials.gov processed this record on January 16, 2009